Tri-Estarylla
- Product NDC
- 0781-4060
- 11-digit product format
- 007814060
- Labeler code
- 0781
- Product ID
- 0781-4060_bcf47853-6415-b85e-f240-d5be6e5b522d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- norgestimate and ethinyl estradiol
- Dosage form
- KIT
- Labeler
- Sandoz Inc
- Application
- ANDA090793
- Marketing category
- ANDA
- Marketing start
- 2013-02-01
- Marketing end
- 0000-00-00
- Active strength
- 0
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 0781-4060 | D | Discontinued by firm | 2026-07-31 | ||
| excluded package | package | 0781-4060 | 0781-4060-15 | D | Discontinued by firm | 2026-07-31 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090793-001 | TRI-ESTARYLLA | ETHINYL ESTRADIOL; NORGESTIMATE | 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG | TABLET / ORAL-28 | AB | 2013-01-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A090793-001 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A090793-001 | TRI-ESTARYLLA | 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG | TABLET / ORAL-28 | AB | 2013-01-30 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A090793-001 | AB | 1 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Tri-Estarylla | NORGESTIMATE AND ETHINYL ESTRADIOL | A-S Medication Solutions | f7f7c073-48e0-4065-970b-8103d76b6eb0 | 2026-01-27 | Boxed warning, Warnings, Adverse reactions | 090793 ANDA090793 |
| Tri-Estarylla | NORGESTIMATE AND ETHINYL ESTRADIOL | Bryant Ranch Prepack | 6560d15f-6ce9-4f0e-9b59-043dec35ddd9 | 2024-05-21 | Boxed warning, Warnings, Adverse reactions | 090793 ANDA090793 |
| norgestimate and ethinyl estradiol | NORGESTIMATE AND ETHINYL ESTRADIOL | AvKARE | a3cfd79e-a344-1dfc-e053-2995a90a1ab7 | 2024-01-10 | Boxed warning, Warnings, Adverse reactions | 090793 ANDA090793 |
| Tri-Estarylla | NORGESTIMATE AND ETHINYL ESTRADIOL | Xiromed, LLC. | 1ba8a8ab-eb09-0807-47d4-6b4055d10d91 | 2023-08-01 | Boxed warning, Warnings, Adverse reactions | 090793 ANDA090793 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0781-4060-15 | EA - Each | 0781-4060 | 60e890b3-aa9d-4720-91d8-445ee23fa155 | 1 | 2013-04-01 |